Sensor set

ABSTRACT

A sensor set is provided for sensing of a body characteristic, such as glucose. The sensor set includes a mounting base for the sensor including a shim adapted to prevent pull up of the sensor and a connector to connect to the mounting base and has an improved structure for connecting the mounting base to the connector. The connector may contain sensor electronics for wired or wireless communication to an external monitor or display. The mounting base includes latch arms and the connector adapted to fit and lock into latch recesses on the connector and includes anti-rotation arms adapted to fit into anti-rotation arm recesses on the connector.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 15/347,521, filed on Nov. 9, 2016, the entirety of which isherein incorporated by reference, which is a continuation-in-partapplication of U.S. patent application Ser. No. 14/938,458, filed onNov. 11, 2015, the entirety of which is herein incorporated byreference. Also, the present disclosure claims the benefit of andpriority to U.S. Provisional Application No. 62/400,987, filed on Sep.28, 2016, the entirety of which is herein incorporated by reference.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention generally relates to connection arrangementsparticularly for use in a sensor set and insertion set for monitoring abody characteristic of the body, such as glucose. More particularly, thepresent invention relates to connectors for coupling components of asensor set including a mounting base or test plug with a connector.

Description of the Related Art

In recent years, a variety of electrochemical sensors have beendeveloped for a range of applications, including medical applicationsfor detecting and/or quantifying specific agents in a patient's bloodand other body fluids. As one example, glucose sensors have beendeveloped for use in obtaining an indication of blood glucose levels ina diabetic patient. Such readings can be especially useful in monitoringand/or adjusting a treatment regimen which typically includes regularadministration of insulin to the patient. In this regard, blood glucosereadings are particularly useful in conjunction with semi-automatedmedication infusion pumps of the external type, as generally describedin U.S. Pat. Nos. 4,562,751; 4,678,408; and 4,685,903; or automatedimplantable medication infusion pumps, as generally described in U.S.Pat. No. 4,573,994.

Relatively small and flexible electrochemical sensors have beendeveloped for subcutaneous placement of sensor electrodes in directcontact with patient blood or other extracellular fluid, wherein suchsensors can be used to obtain periodic readings over an extended periodof time. In one form, flexible transcutaneous sensors are constructed inaccordance with thin film mask techniques wherein an elongated sensorincludes thin film conductive elements encased between flexibleinsulative layers of polyimide sheet or similar material. Such thin filmsensors typically include exposed electrodes at a distal end forsubcutaneous placement in direct contact with patient blood or the like,and exposed conductive contact pads at an externally located proximalend for convenient electrical connection with a suitable monitoringdevice. Such thin film sensors hold significant promise in patientmonitoring applications, but unfortunately have been difficult to placetranscutaneously with the sensor electrodes in direct contact withpatient blood or other body fluid. Improved thin film sensors andrelated insertion sets are described in commonly assigned U.S. Pat. Nos.5,390,671; 5,391,250; 5,482,473; 5,299,571; 5,586,553 and 5,568,806,which are incorporated by reference herein.

U.S. 2008/0064944 (U.S. Pat. No. 7,660,615), which is hereinincorporated by reference, discloses a known insertion set coupling. Itincludes a mounting base for a subcutaneously placed foil sensor. Themounting base itself has a flat underside provided with a pressuresensitive adhesive allowing the mounting base to be stuck on the surfaceof a patient's skin as a stick-on patch. The coupling is providedbetween the mounting base and a cable connector by means of acylindrical connector fitting extending from the mounting base. Thisfits within a corresponding socket of the cable connector. “O” ringsaround the base of the cylindrical connector fitting provide a seal. Theend of the connector fitting is partially cut away leaving a “D” crosssection and producing a flat surface parallel to the axis of theconnector fitting. A contact-bearing head of the sensor foil issupported on this flat surface. When the connector fitting and thesocket engage, spring contacts within the socket touch and connect tothe contact pads the sensor foil.

Currently, there are sensor sets that include a mounting base, forplacement on the patient's skin, which can be coupled to a connectorwith suitable sensor electronics (wired or wireless). Because themounting base may be sold separately, it is possible to attachincompatible components together, which can compromise the sensor data.In addition, the structure of the current sensors allows for limitednumber of contact pads, and respective sensor electrodes.

SUMMARY OF THE INVENTION

In aspects, a sensor set for sensing a characteristic of a patient isprovided, the sensor set comprising a sensor having a distal segmentthereon at a distal end for generating at least one electrical signalrepresentative of a characteristic, such as blood glucose, of a patient,the sensor including at least two contact pads at a proximal end,wherein each of the at least two contact pads are coupled to the distalsegment to receive the electrical signals therefrom; a mounting baseoperable for mounting onto a patient's skin, the mounting base includinga connector fitting generally at a rear end of the mounting base,wherein the connector fitting includes a tubular element having acentral bore formed therein for pass through reception of a portion ofthe sensor, a connector operable to couple to the mounting base, whereinthe connector includes a tubular recess sized to receive the connectorfitting of the mounting base and at least two connector contacts thatare operable to be electrically coupled to the at least two contact padsof the sensor when the mounting base is coupled to the connector,wherein the connector fitting includes a key formed at one end, whereinthe proximal end of the sensor folds around the key such that at leastone of the at least two contact pads is on a first side of the key andat least one other of the at least two contact pads is on a second sideof the key. The distal segment may include electrodes for measuringblood glucose which may for example be configured in a potentiostat. Thecoupling between the distal segment and the contact pad may includeelectronics to power the sensor and/or process the signals. The sensormay be a foil with conductor tracks and electronic components producedaccording to known thin film technology.

A test plug may be included as part of the sensor set in addition to themounting base. The test plug may be sold as part of the sensor set orseparately. It is also possible to sell components of the sensor set,such as the mounting base or the connector, without the othercomponents.

The at least two connector contacts of the connector may be compressiblepins. In still further embodiments, the compressible pins compress intothe first side of the key and the second side of the key when themounting base is coupled to the connector.

It is also envisioned that a test plug may be included, which inconstruction is the same as the embodiment discussed above, but in whichthe sensor is replaced by a flexible circuit foil having the contactpads and, in place of the coupling to a distal segment, has circuits togenerate test signals.

The sensor or test plug circuit foil may include a shorting pathallowing for a shorted reference electrode and counter electrode.Alternatively, or in addition, the sensor or test plug circuit mayinclude a resistor.

The key may be substantially oval or rectangular in shape. Inembodiments, the first side of the key is substantially flat. The secondside of the key may also be substantially flat or it may include asubstantially flat end portion and a step portion. One or both sides ofthe key may include seats or flats to receive the proximal end of thesensor. In embodiments, the key includes at least one prong adapted tofit into a prong recess formed in the mounting base. The first side ofthe key is substantially flat.

The mounting base may include at least one arm generally adjacent to thetubular element of the connector fitting, wherein the at least one armis formed to fit into at least one corresponding arm recess formed inthe connector when the connector is connected to the mounting base.

The connector fitting may include a first side rail formed on a firstside of the connector fitting and a second side rail formed on a secondside of the side rail, wherein the first side rail and second side railare operable to slide into a first slot formed in the mounting basetubular recess and a second slot formed in the connector tubular recesswhen the connector is connected to the mounting base.

The connector may include sensor electronics, for example including awireless transmitter operable to transmit signals from the mountingbase. The at least two sensor electrodes may be operable to generate atleast two electrical signals representative of the characteristic andthe at least two connector contacts may be operable to receive the atleast two electrical signals. These electrical signals may betransmitted via wireless transmitter or transmitted over wire.

The mounting base and the connector may have releasably interengageablesnap fit latch members operable to lock the mounting base to theconnector.

It may be helpful to envision the key as being an extension of thetubular element of the connector fitting from which sectors or segmentshave been cut-away. Thus is the case of a “D” section key for example asshown in U.S. 2008/0064944 the cut-away portion is the lower half of thetubular element. This does not imply that the key is actuallymanufactured by starting with a cylinder and removing material, but thisis useful to define the finished shape.

According to a second aspect, a connector system comprises: a connectorfoil having contact pads thereon at an end portion; a cylindricalconnector fitting having a cylindrical element with a key formed at itsdistal end, said key being defined by cut-away portions of thecylindrical element to produce two flat surfaces each parallel to theaxis of the cylindrical element, which flat surfaces face away from oneanother; wherein the end portion of the connector foil lies against afirst one of said flat surfaces with the contact pads facing away fromthe first flat surface; a socket unit with a tubular recess sized toaccommodate the cylindrical element and having contacts positioned toengage the contact pads of the connector foil, the socket unit having astructure occupying the space vacated by said cut-away portions. Theconnector foil may wrap around the end of the key so as to lie on bothflat surfaces with contact pads facing away from the flat surfaces. Asan alternative to the foil wrapping around the end of the key, it maylie only against one side of the key and the structure occupying thespace vacated by said cut-away portions may comprise spring contacts onone side of the key and a projection on the inside of the tubular recesson the other side of the key. The first flat surface may lie on adiameter of the cylindrical element. Thus, on each side of the key thereare either contacts or a projection being part of the socket. This helpsstabilize the connector system, leading to a more reliable connection.

It is also envisioned that the end of the key may have a predeterminedprofile, and an inner end of the tubular recess may have a complementaryinter-engaging profile. This can be useful to prevent engagement ofnon-compatible components.

Further stability can be provided by the use of side walls on the flatsurfaces of the key to protect the connector foil. Preferably the sidewalls are at least as high as the foil is thick, the foil therebyresting in a shallow cradle on the flat surface of the key. Inarrangements under the first folds over the end of the key side wallsmay only be on the first surface.

According to a yet further aspect there is provided a sensor set forsensing a characteristic of a patient, the sensor set including theconnector system of the above described aspect wherein the connectorfoil comprises a medical sensor having the contact pads at a proximalend and a sensing structure at a distal end and a medial section,wherein the tubular element is formed as part of a mounting baseoperable for mounting onto a patient's skin and has a central bore forpass through reception of the medial section of the medical sensor. Inan alternative arrangement, there is provided a test plug including theabove described connector system, wherein the connector foil comprises atest circuit to test equipment coupled to the socket unit when the plugunit and the socket unit are connected.

In another aspect, a sensor set is provided for sensing a characteristicof a patient, the sensor set comprising: a sensor having at least twosensor electrodes thereon at a distal end for generating at least oneelectrical signal representative of a characteristic of a patient, thesensor including at least two contact pads at a proximal end, whereineach of the at least two contact pads are conductively coupled to atleast one of the at least two sensor electrodes; a mounting base adaptedto mount onto a patient's skin and to connect the sensor to sensorelectronics, the mounting base including a connector fitting generallyat a rear end of the mounting base, wherein the connector fittingincludes a cylindrical element having a central bore formed therein forpass through reception of a portion of the sensor, a connector adaptedto couple to the mounting base, wherein the connector includes acylindrical recess sized to receive the connector fitting of themounting base and at least two connector contacts that are adapted to beelectrically coupled to the at least two contact pads of the sensor whenthe mounting base is coupled to the connector, wherein the mounting baseincludes one or more latch arms and the connector includes one or morelatch recesses, and wherein the one or more latch arms are adapted tofit and lock into the one or more latch recesses when the mounting baseis coupled to the connector, and wherein the mounting base furtherincludes one or more anti-rotation arms and the connector includes onemore anti-rotation arm recesses, wherein the one or more anti-rotationarms are adapted to fit into the one or more anti-rotation arm recesseswhen the mounting base is coupled to the connector. The anti-rotationarms may be wider than their height. The one or more latch recesses arethe same as the one or more anti-rotation arm recesses, such that theone or more latches fit into the same recesses as the one or moreanti-rotation arms.

The mounting base may further include one or more lockout columnsextending in the same direction as the one or more latch recesses andthe connector includes one or more lockout pockets adapted to fit thelockout columns, wherein when the mounting base is coupled to theconnector.

A test plug may be adapted to connect to the connector, with similarconnections. For example, the test plug may include one or more testplug latch arms adapted to fit and lock into the one or more latchrecesses of the connector when the test plug is coupled to theconnector, and the test plug may further include one or more test pluganti-rotation arms adapted to fit into the one or more anti-rotationrecesses of the connector when the test plug is coupled to theconnector. The test plug may include one or more anti-rotation armextensions between a central section of the test plug and theanti-rotation arms, wherein the anti-rotation arm extensions slope fromthe top of the central section to the anti-rotation arm extensions. Thetest plug may also include one or more test plug lockout columnsextending in the same direction as the one or more test plug latchrecesses adapted to fit into the lockout pockets of the connector whenthe test plug is coupled to the connector.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present disclosure, referenceis now made to the following figures, wherein like reference numbersrefer to similar items throughout the figures:

FIG. 1 illustrates a perspective view of a connector and a mountingbase.

FIG. 2 illustrates a perspective view of a connector and test plug.

FIG. 3 illustrates an expanded view of a connector with wireless sensorelectronics.

FIG. 4 illustrates a perspective view of a sensor set with insertiontool.

FIG. 5 illustrates an expanded view of a mounting base, includingsensor, and insertion tool.

FIG. 6 illustrates an expanded perspective view showing assembly of themounting base components, including a sensor.

FIG. 7 illustrates an underside, expanded view of the mounting base,including sensor, shown in FIG. 6.

FIG. 8 illustrates an underside view of the mounting base shown in FIG.6.

FIG. 9 illustrates another expanded view of a mounting base withretainer cap.

FIG. 10 illustrates another expanded view of a mounting base withretainer cap.

FIG. 11 illustrates an underside view of the retainer cap of FIG. 11.

FIG. 12 illustrates a perspective view of a mounting base with retainercap.

FIG. 13 illustrates a perspective view of an insertion needle installedon an assembled mounting base and retainer cap.

FIG. 14 illustrates a sectional view taken generally on the line 11-11of FIG. 10.

FIG. 15 illustrates a front end perspective view of a connector in theform of a cable connector.

FIG. 16 illustrates an exploded perspective view of a connector in theform of a cable connector.

FIG. 17 illustrates a perspective view showing sliding removal of theinsertion needle from a sensor set, following placement of the mountingbase onto the skin of a patient.

FIG. 18 illustrates a perspective view showing a sensor set and cableconnector mounted onto the skin of a patient, following removal of theinsertion needle.

FIG. 19 illustrates a top view of a test plug.

FIG. 20 illustrates a side view of a test plug.

FIG. 21 illustrates a perspective view of a test plug.

FIG. 22 illustrates a partial perspective view of a connector.

FIG. 23 illustrates a perspective view of a test plug.

FIG. 24 illustrates a partial perspective view of a mounting base ortest plug.

FIGS. 25A-C illustrate sectional views taken along a socket fitting of amounting base.

FIGS. 25D-E illustrate perspective, expanded views of pins used ascontacts in a mounting base.

FIG. 25F illustrates a cut away view of a test plug.

FIG. 26 illustrates a perspective view of a mock-up showing theconnection between a connector and a test plug or a mounting base.

FIG. 27A-27F illustrates cut away views of various lock-out connectionsbetween test plug or a mounting base and a connector.

FIG. 28 illustrates a diagram of contact pads for a sensor.

FIG. 29 illustrates a perspective view of a mounting base.

FIG. 30 illustrates a perspective view of a mounting base.

FIG. 31 illustrates a side view of a mounting base.

FIG. 32 illustrates a partial perspective view of a connector.

FIG. 33 illustrates a partial, close-up side view of a connector.

FIG. 34 illustrates a perspective view of a mounting base.

FIG. 35 illustrates a partial perspective view of a connector.

FIG. 36 illustrates a perspective view of a test plug.

FIG. 37 illustrates a perspective view of a test plug.

FIG. 38 illustrates an internal, partially cut-away view of a mountingbase with sensor.

DETAILED DESCRIPTION

The following description and the drawings illustrate specificembodiments sufficiently to enable those skilled in the art to practicethe system and method described. Other embodiments may incorporatestructural, logical, process and other changes. Examples merely typifypossible variations. Individual elements and functions are generallyoptional unless explicitly required, and the sequence of operations mayvary. Portions and features of some embodiments may be included in, orsubstituted for, those of others. In particular, any structure describedin respect to the coupling between a test plug and a connector appliesalso to the coupling between a corresponding mounting base and theconnector.

As shown in the exemplary drawings, an improved sensor set is providedfor monitoring a body characteristic of the body. Also provided is animproved structure of the connections between the various components ofthe sensor set. One example body characteristic is the blood glucoselevel of the body. As shown in FIG. 1, an embodiment of a sensor setincludes a sensor mounting base 30 and connector 20. The connector 20shown in FIG. 1 includes wireless sensor electronics that have a sensortransmitter (not shown) inside the housing.

Further detail of the connector 20 is given below in the discussion ofFIG. 3. The mounting base 30 illustrated in FIG. 1 serves as a mount forthe foil of a thin film sensor, as shown best in FIGS. 6 and 7 below.The mounting base 30 consists of a housing with a flat undersideoptionally provided with a pressure sensitive adhesive (not shown)allowing the mounting base 30 to be stuck on the surface of a patient'sskin as a stick-on patch. One edge of the mounting base 30 comprises acylindrical connector fitting 36 having a cylindrical or tubular element42 with an axial bore 44. The cylindrical or tubular element 42 has acut-away tip defining a key 50 including a flat surface parallel to itsaxis. Exposed contact pads 18 on a proximal end on the sensor aresupported by this flat surface. A medial section of the foil of thesensor passes foil through the bore 44 of the cylindrical or tubularelement, out through its underside of the mounting base, connecting thecontact pads 18 to sensing elements beneath the skin of the patient. Forsensing glucose concentration the sensing elements could typically bethe electrodes 15 of a potentiostat. The connection between the contactpads and the sensing elements optionally includes processing circuitry.

The sensor mounting base 30 couples to the connector 20 by means of thecylindrical connector fitting 36. The connector 20 has a socket 92 sizedto slide-fit engage with the connector fitting 36 of the mounting base.The cylindrical or tubular element 42 is optionally provided with a pairof spaced apart “O” rings 48 resting in external grooves 46 in itssurface to seal against corresponding surfaces on the inside of thesocket 92 and form a moisture-proof coupling. On each side of theconnector filling 36, the mounting base 30 has resilient latch arms 97and latch tips 98, which can snap into and be retained within latchrecesses 100 on the connector 20. When the mounting base 30 is coupledto the connector 20, the latch tips 98 lock into the latch recesses 100.They can be released by pressing on the latch arms 97 so that theconnector 20 can be removed from the mounting base. A narrow, generallyoval or rectangular shaped fitting key 50 is formed as a rearwardextension of a cylindrical or tubular element adapted to slide into asocket fitting 92 of the connector 20.

As mentioned above, the foremost tip of the connector fitting 36extending from the cylindrical or tubular element 42 comprises a key 50.The key 50 is essentially of a cylindrical shape, either parallel sided,or slightly tapered at an end portion. Out of the shape of this endportion has been removed sectors to leave two or more flat surfacesparallel to the axis of the tubular element. In the arrangement shown inFIG. 1 the key 50 has the whole of its lower half removed such as toform downward facing “D” section. A pair of sectors on the upper side ofthe “D” are removed to produce a pair of flat surfaces separated by acentral ridge. This structure is in greater detail in FIG. 24. The pairof flat surfaces face in an opposite direction from the flat surface ofthe straight side of the “D” shape. A correspondingly shaped structurewithin the socket 92 of the connector 20 enables the connector fittingto be supported from two parallel sides, thereby improving stability. Inthe FIG. 1 arrangement, connection pads on the foil of the thin filmsensor (not shown) supported by the mounting base rest against thesurface forming in cross-section straight side of the “D”. Theseconnection pads engage with spring contacts inside the socket 92 of theconnector 20. Facing in the other direction are the pair of flatsurfaces, which do not carry contacts, but nonetheless engage withcorresponding surfaces of a projection the socket 92 of the connector20.

The connector 20 may also be used with a test plug 130, one embodimentof which is shown, in FIG. 2. Such a test plug 130 may have the samegeneral configuration as regards its connector fitting 36 with respectto the connector 20 connections as does the mounting base 30 shown inFIG. 1. The arrangement of FIG. 2 however shows an important alternativearrangement for the connector fitting 36. Such connector fitting 36 canalso be used as for the mounting base of FIG. 1. In the FIG. 2arrangement as well as the removal of the lower half of the key 50forming a flat surface parallel to the axis of the tubular element 42, aflat surface is formed by removing a sector from the shape of the uppersurface of the key 50. The key 50 thereby has a rounded side trapeziumshape in cross-section. This arrangement is also shown in FIGS. 19-23and described below in more detail. The pair of flat surfaces facing inopposite directions enable the test plug of FIG. 2, or the mounting baseof FIG. 1, when provided with the FIG. 2 connector fitting 36 to besupported from both sides within the connector 20. Also, thisarrangement allows for connection to a foil with a greater number ofcontacts as the connector foil can wrap around the end of the key. Thisprovides one set of contacts on the lower surface and another set ofcontacts on the upper surface. In that case, a stabilizing andcentralizing force can be provided via the contacts within the connector20. When attached to the sensor connector 20, the test plug shown inFIG. 2 provides a tight seal by virtue of the “O” seal rings 48,allowing a patient to wash those components without the danger of waterentering the socket 92. This is particularly useful in the embodimentswith wireless transmitters, especially those that are sealed within theconnector 20 Like the mounting base 30, the test plug 130 includes a key50, adapted to slide into the socket fitting 92 of the connector 20. Thetest plug 130 also includes latch arms 97 and latch tips 98, which caninteract with latch recesses 100 on the connector 20. When the test plug130 is coupled to the connector 20, the latch tips 98 lock into thelatch recesses 100. They can be released by pressing on the latch arms97 so that the connector 20 can be removed. In practice, a sensor kit assold commercially may comprise a connector, a mounting base and a testplug, where the connector is configured to be connectable physically andelectrically compatible with both the test plug and the mounting base.

For the sake of uniformity, there is herein continual reference to the“tubular element” 42 forming part of the connector filling 36 in boththe case of the mounting base and the test plug. It is however envisagedthat the tubular element be solid (i.e. with no bore through it). Thismay be the case if all of the circuitry for the test plug is mounted onthe contact foil, or in the case of the sensor if connection to thedistal end need not pass right through the element.

The test plug 130 also allows for testing of wireless transmitters orother sensor electronics in the connector 20 without receiving data fromany sensor. Thus sensor electronics can be tested alone and withoutexternal sensor noise. For example, the test plug may be a simple testerthat generates a single current, such as 53.5+/−10%) that can bedetected by sensor electronics and read by a monitoring device. Incertain embodiments, the tester shorts the reference and counterelectrodes, which are discussed herein.

An example connector 20 is shown in FIG. 3, which includes sensorelectronics with a wireless transmitter. A housing consists of an uppershell housing portion 201 and a lower shell housing portion 207. Thehousing encases a circuit board 202 and an antenna 203. The circuitboard can include an application specific integrated circuit (ASIC).Although one preferred antenna shape is shown in in FIG. 3, but otherconfigurations are contemplated that could allow for fitting a suitableantenna in the connector. A contact plug/pin housing 206 holds moldedpins 205 and sits inside the housing 201/207 forming the interior of thesocket 92 such that when the sensor mounting base 30 is connected to theconnector 20, the sensor electronics on the circuit board 202 canreceive signals from the sensor housed in the mounting base 30 and themounting base 30 is held securely and stably in contact with theconnector 20 by virtue of the profile of the key 50 on the connectorfitting 36. Sensor electronics including wireless transmitters arediscussed, for example, in U.S. Pat. No. 7,602,310, which is hereinincorporated by reference.

As an alternative in the arrangements described with respect to FIGS. 1and 2 the connector may comprise a termination of a cable wired directlyto a monitor, which may or may not include a display. It may includeonly a wire connector or may include some sensor electronics that alsoinclude a wire connector, depending on the needs of the user.

The connector 20 may include a rechargeable power source, such as arechargeable battery. The rechargeable power source may be charged usinga charger that holds the connector or is otherwise coupled to theconnector to recharge the power source. Example chargers are shown, forexample, in U.S. patent application Ser. No. 12/434,076, filed on May 1,2009, which is herein incorporated by reference.

The sensor set and any related monitor may be of the type suitable fordetermining glucose levels in the body and/or body fluids of the userand may be used in conjunction with automated or semi-automatedmedication infusion pumps of the external or implantable types asdescribed in U.S. Pat. Nos. 4,562,751, 4,678,408, 4,685,903, and4,573,994, which are herein incorporated by reference, to deliverinsulin to a diabetic patient. However, it will be recognized that theinvention may be used in arrangements to determine the levels of otheragents, characteristics or compositions, such as hormones, cholesterol,medication concentrations, pH, oxygen saturation, viral loads (e.g.,HIV), or the like. The sensor set may also include the capability to beprogrammed or calibrated using data received by the sensor electronics,or may be calibrated at the monitor device. The sensor system isprimarily adapted for use in subcutaneous human tissue. However, it maybe placed in other types of tissue, such as muscle, lymph, organ tissue,veins, arteries or the like, and be used in animal tissue. It will beunderstood that the term “patient” can be broadly construed to encompasshumans and other animals, and that the term “blood” encompasses patientblood and other extracellular patient fluids. Embodiments may providesensor readings on an intermittent or continuous basis.

The sensor set primarily discussed herein uses an electrode-type sensor.However, the system may use other types of sensors, such as chemicalbased, optical based or the like. The sensors may be of a type that isused on the external surface of the skin or placed below the skin layeror the user. Certain surface mounted sensors could utilize interstitialfluid harvested from underneath the skin.

Where the connector has sensor electronics including a wirelesstransmitter, the sensor electronics generally include the capability totransmit data. Alternatively, these sensor electronics may include areceiver or the transmitter may be a transceiver with the capability toreceive data. FIGS. 4-18 show a direct connection to a wire that cancarry signals to separate sensor electronics, which may include amonitor or display and may also (or alternatively) transmit data to anexternal monitor or display.

As shown in FIGS. 6-8, the flexible thin sensor 12 foil comprises arelatively thin and elongated element which can be constructed accordingto so-called thin mask techniques to include elongated conductiveelements 24 (FIG. 6) embedded or encased between layers of a selectedinsulative sheet material such as polyimide film or sheet. In someembodiments, the flexible thin sensor may be contained in a flexibletube to provide support. However, it is possible for a thicker sensor tobe stiff enough to facilitate sensor to base assembly and to reduceinstances of sensor kinks without a flexible tube. A thickness of about17-40 μm is sufficiently thick to provide this stability, for example 25μm. The proximal end or head 16 of the sensor 12 is relatively enlargedand defines the conductive contact pads 18, which are exposed throughthe insulative sheet material for electrical connection to the cable 22,as will be described in more detail. An opposite or distal segment ofthe sensor 12 includes the corresponding plurality of exposed sensorelectrodes 15 for contacting patient body fluid when the sensor distalsegment is placed into the body of the patient. The sensor electrodes 15generate electrical signals representative of patient condition,generate electrical signals representative of patient condition, whereinthese signals are transmitted via the contact pads 18 and connector,which may include sensor electronics (wired or wireless) or just aconnection to a wire, to an appropriate monitoring device (not shown)for recordation and/or display to monitor patient condition. Furtherdescription of flexible thin film sensors of this general type may befound in U.S. Pat. No. 5,391,250, which is herein incorporated byreference. Further description of wired sensor electronics may be foundin U.S. Pat. No. 7,602,310, which is herein incorporated by reference.

In addition to the methods shown in the patents incorporated herein byreference, it is possible to fabricate the sensor with a no-pre-platingwet etching process or a pulsed+DC plating process, which allows foruniform platinum morphology. In an enzyme entrapment method, the glucoseoxidase (GOx) enzyme is entrapped within a photosensitive polymer thatcrosslinks upon UV exposure. With this type of photosensitive polymer,the need for a glutaraldehyde crosslink step is eliminated, providingthe ability to have the enzyme only over the sensing working electrodesthrough selective curing of the photosensitive polymer.

The sensor 12 is carried by the sensor set, specifically on the mountingbase 30, which is adapted for placement onto the skin of a patient(FIGS. 17-18) at the selected insertion site. The sensor set generallycomprises a compact mounting base 30 having a generally planar or flatunderside surface 32 (FIGS. 7-8) attached to an adhesive patch 34 forpress-on adhesive mounting onto the patient's skin. The patch may besized such that it has as much adhesion to skin as possible while notbeing too large for comfort or to easily fit on a patient. The adhesivepatch may be made from a material with stretch to increase comfort andto reduce failures due to sheer. It is understood that alternativemethods for attaching the mounting base to the skin of a patient, otherthan an adhesive patch, also may be contemplated. The mounting base 30is generally constructed out of lightweight plastic so that it may becomfortably worn throughout numerous activities by a patient. Themounting base 30 may be constructed as a unitary molding of lightweightplastic to include a connector fitting 36 for slide-fit coupling withthe sensor connector 20, which may include a wireless transmitter, wiredelectronics, or merely a cable for connection to external sensorelectronics and/or monitor. A bore 44 through the connector fitting 36leads to an upwardly open recessed groove or channel 38 formed in anupper surface 40 of the mounting base 30 (e.g., FIG. 6) to receive andsupport the sensor 12 between its proximal end or head 16 and its distalend.

FIGS. 5-8 show a mounting base 30 to comprise a rearwardly projectingtubular element 42 defining a central bore 44 aligned generallycoaxially with a rearward end of the recessed channel 38. The tubularelement 42 includes external grooves 46 (FIG. 5) for receiving sealrings 48 adapted for sealed slide-fit engagement with the cableconnector 20, as will be described. The rearward end of the tubularelement 42 terminates in a key 50 formed as a rearward extension thereofcomprising a “D” section with a pair of flat surfaces of the apex of itscurved back. The key thus has flat surfaces extending parallel to theaxis of the tubular element on each side and facing away from eachother. When engaged with the connector the flat surface comprising thestraight side of the “D” supports contact pads 18 against springcontacts within the connector, while the pair flat surfacescorresponding to the material removed from apex of the “D” engage with astructure within the connector providing stability and a reaction force.

FIGS. 19-23 show coupling arrangements in respect of a test plug andconnector. Identical arrangements are envisaged, however forcorresponding mounting bases. In the description that follows both themounting base and the test plug variants will be discussed. In the caseof the mounting base the contacts referred to contacts on the proximalend of a sensor leading to electrodes directly or via circuitry mountedin the electrodes. In the case of the test plug the electrodes are theelectrodes of test circuitry. The configuration or layout of thecontacts is identical for the test plug and the actual sensor as isapparent from the description below referring to FIG. 28.

As shown in FIGS. 19-21, the top and the bottom of the key 50 are eachsubstantially flat and each incorporate shallow flats or seats 152 and153. The recessed seats are sized and shaped to receive and support aflexible test circuit, or in the case of the mounting base as shown inFIG. 9, the proximal head 16 of the sensor 12, with the proximal end ofthe elongated sensor 12 extending from said head 16 through the bore 44and lying within the recessed channel 38. The recessed seats may includea shelf 154 (FIG. 20) that allows the bottom of the key to step from anarrow depth to a slightly wider depth. This shelf allows for the uniquefitting of current keys into only compatible connecting pieces on sensorconnectors, which include matching recesses. The shelf further improvestolerance and robustness of the connections. As can be seen in FIG. 21,the proximal head 16 of the flexible test circuit or of the sensor 16may be configured such that it folds around the key 50 so that thecontacts are on both seats 152 and 153. In this configuration, theflexible test circuit or the proximal head 16 of the flexible testcircuit or of the sensor may include 2 sets of contact pads 18. Forexample, in FIG. 28 one embodiment of a schematic for the contact padsis shown. The contact pads shown are two for a reference electrode (180,181), two for a counter electrode (184, 185), and one for each of twoworking electrodes (182, 183).

A shorting path 186 allows for a shorted reference electrode/counterelectrodes and a resistor may be used to account for additional workingelectrode(s) and counter electrode(s). By allowing for additionalcontact pads in the same space, additional electrodes may be used in thesensor without requiring additional size of the mounting base orconnector. In the configuration showed in FIG. 28, the fold of thesubstrate 180 is generally along the line 1800-1800 so that one set ofcontact pads is on each side of the key 50. In alternative embodiments asingle set of contacts could be included on just one side of the key 50,as shown in other embodiments herein.

As shown in FIG. 23, the key 50 may include prongs 501 and 502 that fitinto respective prong recesses in the connector (not shown) and lockoutother non-compatible connectors. The prongs also help assist inrotational stability of the coupling and assist in ensuring a goodconnection between the connector and mounting base. Respective prongrecesses in the connector are shown in FIG. 31 (a partial view of theconnector).

In alternate embodiments, shown for example in FIG. 8, the rearward endof the tubular element 42 terminates in a generally D-shaped orhalf-circle fitting key 50 with a pair of cut-outs at its top formed asa rearward extension of the tubular element and which incorporates ashallow recessed flat or seat 52 formed at the rearward end of the bore44. The recessed seat 52 receives and supports the proximal head 16 ofthe sensor 12.

In still further embodiments, the rearward end of the tubular element 42terminates in a generally D-shaped or half-circle fitting key 50 thathas been cut out on top to form a rail 503 (as shown in FIG. 24). Thisrail 503 corresponds to a trench 125 (as shown in FIG. 25B) in themounting base. The rail provides additional stability and prevents othernon-compatible components, which do not include the rail/trenchconfiguration, from coupling with components that have the rail/trenchconfiguration.

In embodiments, the head 16 of the sensor 12 is secured and seatedwithin the recessed seat(s) 52 or 152, 153 by means of a suitableadhesive or the like. In addition, subsequent to placement of the sensor12 through the bore 44, the bore 44 may be hermetically sealed withsuitable sealant such as curable silicone sealer or the like.

For facilitated slide-fit engagement with the sensor connector 20, theseat 52 may be formed to ramp angularly rearwardly and upwardly from acentral axis of the bore 44, thereby supporting the sensor head 16 withthe contact pads 18 presented downwardly and angularly rearwardly.

Because it is possible for both configurations of keys discussed aboveto exist in various mounting bases of differing compatibilities, the keyfurther serves to prevent use of one configuration of mounting base 30with the other configuration of connector 20. Thus, the key allows toensure compatibility of sensors to connectors and to related monitorsand prevents chemically or technically incompatible parts from beingused with each other.

In embodiments, the recessed channel 38 in the mounting base 30 thusreceives and supports the proximal segment of the thin film sensor 12.As shown in FIGS. 6, 9 and 10, the recessed channel 38 extends forwardlyfrom the fitting bore 44 with a generally horizontal orientation, andthen turns downwardly and forwardly at an angle of about 45 degrees toextend along an angled face 53 within a forwardly open gap 54 formed inthe front end or nose of the mounting base. In some embodiments, acannula 58 is slidably fitted over at least a portion of the proximalsegment of the sensor 12, to extend also over the distal segment toencase and protect the sensor. In the preferred form, the cannula isconstructed from a lightweight plastic material such as a urethane basedplastic, and has a double lumen configuration. The double lumen cannula58 is especially suited for slide-fit engagement with and disengagementfrom the insertion needle 14, as will be described in more detail, andincludes a window 59 to expose the sensor electrodes 15. The specificcannula construction for receiving and supporting the sensor 12, and forslidably interfitting with the insertion needle 14, is shown anddescribed in more detail in U.S. Pat. No. 5,586,553, which is hereinincorporated by reference.

In further embodiments, an insertion method is included as part of thesensor set. For example, a retainer cap 60 allows for insertion of thesensor set. In embodiments, the proximal end of the sensor 12 and theportion of the cannula 58 thereon are folded as shown in FIG. 10 tofollow the contour of the mounting base channel 38, so that the distalsegment of the sensor and the cannula thereon extend and protrudedownwardly and forwardly from the front of the mounting base 30. Thesensor and cannula may be captured and retained in this orientation by aretainer cap 60 shown in FIGS. 10-12. This retainer cap 60 also may beformed conveniently and economically as a lightweight plastic moldingand includes means for quick and easy snap fit installation onto themounting base 30. When the retainer cap 60 is assembled with themounting base 30, these components cooperatively close the top of thechannel 38 to capture and retain the sensor and cannula therein. Theretainer cap 60 further defines a needle port 78 (FIGS. 12 and 13) forpass through reception of the insertion needle 14. The insertion needle14 has a hollow and longitudinally slotted configuration (FIG. 14) witha pointed or sharpened tip and a rear end anchored to an enlarged hub80. The hub 80 is manually manipulated to fit the needle 14 through thecap port 78, in order to slide the slotted needle into engagement withthe cannula 58 within the forwardly and downwardly angled portion of thechannel 38. In this regard, the needle port 78 is sized and shaped toorient the insertion needle 14 for proper angular and rotationalalignment with the cannula 58 to ensure correct slide-fit engagementtherebetween.

More particularly, the hub 80 includes an enlarged tab-like wing 82adapted for easy grasping and handling between the thumb and indexfinger. This enlarged wing 82 projects upwardly from a bifurcated nose84 which is sized and shaped to seat onto the mounting base uppersurface 40, on opposite sides of a raised central section 86 of theretainer cap 60. The hub nose 84 is contoured to defined keyed alignmentor guide surfaces 88 for matingly contacting associated keyed alignmentsurfaces on the mounting base 30, defined by the upper surface 40 and anangularly presented forward face 90 of the support brackets 68. Withthis geometry, the hub 80 is slidably displaced against the mountingbase 30 with the insertion needle 14 extending into and through the capport 78 at the correct angular and rotational orientation for slide-fitengagement with and disengagement from the cannula 58. In the preferredform, the insertion needle 14 slidably assembles with the cannula 58 asdescribed in U.S. Pat. No. 5,586,553, which is herein incorporated byreference, to provide a generally circular cross sectional profile (FIG.14) protruding from the mounting base.

FIGS. 15-16 show the connector 20 for coupling with the assembledinsertion set 10. A cable connector is used for wired connection to amonitor or display. The connecting components of the cable connector caninstead be on a connector including sensor electronics that allow wiredor wireless transmission to a monitor or display. As shown, the cableconnector 20 comprises a compact coupling element which can also beconstructed from lightweight molded plastic. The cable connector 20defines a socket fitting 92 for mating slide-fit engagement with therear cable fitting 36 of the mounting base 30. This socket fitting 92has a cylindrical entry portion 93 which merges with a generallyD-shaped or half-circle step portion 94 sized to receive the D-shapedkey 50 of the fitting 36. Flat bottomed inserts provided at the top ofthe cylindrical socket provide reaction against the flats at the top ofthe “D” section in FIGS. 6-13. As shown, the socket fitting 92 includesa plurality of conductive contacts 96 (FIG. 15) positioned on the stepportion 94 for electrically coupled engagement with the contact pads 18on the sensor 12 in the case of the mounting base embodiments or thecontact pads 18 on the test circuit in the case of the test plugembodiments, when the insertion set 30 or test plug 130 and cableconnector 20 are coupled together. Referring to FIG. 16, when assembled,seal rings 48 sealingly engage the entry portion 93 of the socketfitting 92 to provide a sealed connection between the components. Thegeometry of the interfitting components 50 and 94 ensure one-wayinterconnection for correct conductive coupling of the cable 22 to thesensor 12.

More advanced insertion tools may also be used to insert the sensor intoa patient. Insertion tools that can interact with the mounting base ofthe present invention are shown, for example, in U.S. Pat. Nos.5,851,197, 6,093,172, and 6,293,925, which are herein incorporated byreference. In embodiments, as shown in FIG. 37, the mounting baseincludes one or more inserter cutouts 77 to interact with an insertiontool, making the interaction more specific to certain insertion tools.The inserter cutouts 77 may also allow for better stability duringinsertion.

In further embodiments, a shim may be installed in the mounting base 30,as shown in FIG. 38 (a partial cut-away view). The shim 17 in installedas part of the sensor 12 to prevent pull-up. It minimizes frictionbetween the sensor and the needle during insertion, eliminates room formotion within the cavity of the mounting base, and improves sensorrigidity along the vulnerable neck-down region of the mounting base.

Several embodiments of the conductive contacts 96 are shown in FIG.25A-F. While certain numbers of conductive contacts are shown in thesefigures, and corresponding numbers of sensor contact pads are shown inother figures herein, it is contemplated that different numbers ofconductive contacts and corresponding sensor contact pads could be usedas long as they are sufficient to determine data related to the sensedbody characteristic. FIG. 25A-C show cut-away views of the socketfitting 92 with the interior conductive contacts 96. FIG. 25A shows thefitting of a generally D-shaped portion 94 with two flats at the top(FIGS. 4-18) and with the conductive contacts 96 being pins that touchthe contact pads of the key 50 when the key is fit into the socketfitting 92. FIG. 25B shows another embodiment where the D-shape has beenslightly cut away and a railing added that fits into the runner 125. Therunner 125 allows for both blocking the non-compatible components frombeing used with this sensor connector but also gives additionalstability, such as rotational stability. FIG. 25C shows an embodimentwhere the conductive contacts are on both sides of the key, so thatthere are 2 sets of pins 96 that will contact the conductive contacts.Further views of the conductive pins are shown in FIG. 25D (pins fromFIGS. 25A and 25B) and in FIG. 25E (pins from FIG. 25C, shown inexpanded form). FIG. 25F shows an embodiment of a test plug 130 fittinginto a connector 20. The form of the pins allows for some compression ofthe pins when the key is inserted into the socket. Unlike in a situationwith 2 non-flexible contacts that need exact molding so that they toucheach other, this compression gives assurance that the contact pads willcontact the pins every time. In addition, the pins will provideadditional stability while they push into the contact pads of the key50.

The mounting base 30 and the cable connector 20 are retained inreleasably coupled relation by interengaging snap fit latch members. Asshown in FIGS. 15 and 16, for example, the mounting base 30 is formed toinclude a pair of rearwardly projecting cantilevered latch arms 97 whichterminate at the rearward ends thereof in respective undercut latch tips98. The latch arms 97 are sufficiently and naturally resilient formovement relative to the remainder of the mounting base 30, to permitthe latch arms to be squeezed inwardly toward each other. Thepermissible range of motion accommodates snap fit engagement of thelatch tips 98 into a corresponding pair of latch recesses 100 formed inthe cable connector 20 on opposite sides of the socket fitting 92,wherein the latch recesses 100 are lined with latch keepers 102 forengaging said latch tips 98. The components can be disengaged foruncoupling when desired by manually squeezing the latch arms 97 inwardlytoward each other for release from the latch keepers 102, while axiallyseparating the mounting base 30 from the cable connector 20.

Further as shown in FIGS. 19 and 34 the test plug 130 (not shown in FIG.34) or mounting base 30 (not shown in FIG. 19) includes anti-rotationarms 115 and 116. In certain embodiments, as in FIG. 19, theanti-rotation arms are generally adjacent to the tubular element 42,which includes the key 50. The connector 20 (partially shown in FIG. 22)includes anti-rotation arm recesses 215 and 216, which correspond andfit with the anti-rotation arms. In the embodiment shown in FIG. 22, theconnector also includes catch recesses 217 and 218, which can catchanti-rotation arms if they are formed with hooks, like the latch tips 98of the test plug/mounting base. These anti-rotation components help toprevent rotation of the mounting base 30 and test plug 130 with respectto the connector 20 and also help to ensure that the connector is onlyused with compatible test plugs and mounting bases, avoidingcompatibility issues of physical or technical nature. In furtherembodiments, the width and/or height of the anti-rotation arms may bevaried to lock-out previous non-compatible components. An anti-rotationarm on each side of the tubular element prevents rotation may provideadditional stability. Each anti-rotation arm prevents rotation aroundthe other anti-rotation arm as well as around the tubular element. Suchanti-rotation arms may be incorporated on any of the test plugs ormounting bases described herein. Alternatively, in any such arrangementsthe anti-rotation arms 115, 116 can be provided on the connector 20 andthe corresponding recesses 215, 216 can be provided on the test plug 130or mounting base 30.

From the arrangement described with reference to FIGS. 19-22 it can beseen that the invention also provides, according to a further aspect, aconnection arrangement to couple a mounting base of a subcutaneoussensor or a test plug substitute for the mounting base, to a connector.Such connection is typically needed to communicate the electricalsignals from the sensor to external equipment, for example, a displayfor blood glucose level or an infusion pump in the case where the systemis being used for diabetes management. The connection arrangementcomprises a body of the mounting base or test plug, said body having amating surface on one side. The connector has a connector interfaceforming part of the connection arrangement with a complementary matingsurface to that of the said body. Protruding from the mating surface ofthe body is a probe 42 with contacts on the end thereof. The connectorinterface has a socket sized to receive the probe 42 and containingcontacts to connect with the contacts on the end of the probe when theconnection arrangement is engaged. On each side of the probe alsoprotruding from the mating surface are a pair of anti-rotation posts115, 116 each spaced from the probe 42. On the complementary surface ofthe connector interface there is a recess 215, 216 on each side of theprobe into which the anti-rotation posts 115, 116 fit. Typically, therecess is much wider than the post, extending further beyond the socketsuch that the anti-rotation post, if it engages the wall of the recessat all, engages the wall closest to the probe and socket. The body alsohas a pair of resilient latch arms 97, 98 which emerge from the body atpoints remote from the mating surface and continue parallel to the bodytowards the mating surface. These latch arms then extend beyond themating surface in the form of upstanding latch posts 98 with outwardlyfacing chamfered tips. The latch arms 97, 98 are resilient they have arelaxed position in which the latch tips 98 are splayed, and acompressed position where the latch tips are moved together, thusreducing the distance between the resilient arms and the body. Therecesses 215, 216 in the complementary surface, one on each side of theprobe are wide enough to accommodate, in addition to the anti-rotationposts 115, 116 the latch posts. Each recess has an outer wall on itsside away from the probe, the outer wall having undercuts complementaryto the latch tips of the latch arms such that with the arms in therelaxed position and hence the tips in the splayed position the latchtips fit in said undercuts and is prevented from withdrawal by thenarrower mouth portion of the slot obstructing the latch posts. Henceseparation of the mating surface and the complementary mating surface isprevented. Squeezing the two latch arms together however moves them tothe compressed position where the latch tips can escape from theundercuts of the recess and the mating surfaces can be separated. Thus,on each side of the probe 42 on the body there are two pairs of posts,one inward pair being responsible to prevent rotation. These rise fromthe mating surface immediately adjacent the probe and hence due to thestiffness of the body easily resist any tendency for the probe torotate. A second pair of posts separated by an air gap from theanti-rotation posts are for latching. Their triangular tips latch intorecesses in the outer walls of the recesses in the complementary surfacewhich form an undercut. These latching posts are on the end of resilientarms connected further back on the body of the mounting base or testplug. Typically they are made of the same material as the mounting baseor test plug body, but because they are relatively thin they areresilient. Squeezing the arms together reduces the air gap between thelatch posts and the anti-rotation posts, making the combination narrowenough to escape the narrower mouth due to the undercut and exit themouth of the recess in the complementary surface. Thus, the latch armsprovide resilience and the anti-rotation posts provide stability againstrotation and both engage the same pair of recesses in the complementarysurface, thus reducing production costs and resulting in the generallysimpler design.

FIG. 26 shows a system connecting a mounting base 30, with a layer ofadhesive on its underside and typically supporting a subcutaneoussensor, to a connector 20, which may comprise a transmitter sending datafrom the sensor via a wireless link to monitoring equipment. Thecoupling of the connector 20 with mounting base 30 may comprise aconnector fitting 36 of the mounting base 30 extending into theconnector 20. The mounting base 30 has an upstanding post 261, fromwhich extends a tubular element 42. The tubular element 42 and a fittingkey 50 of the connector fitting 36 may fit into the connector 20 toconnect it to the mounting base 30. Once connected, the profile of thetransition from the mounting base 30 to the connector 20 is smooth.

It is desirable to provide stability of the system when coupled, as wellas prevent connection with (known as locking out) incompatiblecomponents. This is achieved in the FIG. 26 arrangement using side railsand slots. The housing of the connector 20 may have horizontal siderails which engage with horizontal slots on the mounting base 30. Morepreferably, an upstanding post 261 of the mounting base 30 may havehorizontal side rails which engage with horizontal slots in the housingof the connector 20. Slots each have an entrance at one end and atransverse end block at the other end. Side rails each have a lengthless than that of the distance from the entrance to the end block oftheir respective slot. This allows engagement of the correct side railwith its corresponding slot, but not of a side rail and slot in whichthe side rail is longer than the distance from the entrance to the endblock of the slot.

FIG. 26 shows side rails 260 a and 260 b on the mounting base 30 thatengage with slots 262 a and 262 b in the connector 20. Side rail 260 aand its corresponding slot 262 a may be the same length or differentlengths to side rail 260 b and its corresponding slot 262 b. FIGS.27A-27F show various examples of combinations of side rail lengths thatcould be used to lock out different versions of the mounting base 30 andconnector 20. FIGS. 27A and 27F, for example, show side rails 272 and273 with a great difference in length. FIGS. 27B and 27E show side rails272 and 273 with a less great difference in length, whilst FIGS. 27C and27D show side rails 272 and 273 with little difference in length. Theside rails may also be of the same length as each other. The length ofside rail 272 is set up to match the distance between the entrance andend block 270, whilst the length of slide rail 273 is set up to matchthe distance between the entrance and end block 271 of its correspondingslot, so that a mounting base 30 with either rail length longer than thedistance of its corresponding slot will not engage with connector 20.

Thus, the FIG. 26 arrangement illustrates a system connecting a mountingbase 30, typically supporting a subcutaneous sensor, to a connector 20which typically contains a transmitter sending data from the sensor viaa wireless link, wherein the mounting base 30 comprises a platformhaving on one side an adhesive layer for attachment to a patient, and onthe other side a post 261 with a tubular element 42 extending therefromparallel to the platform, the connector 20 having a housing with asocket positioned to engage the tubular element 42 by means of slidingrails and slots which engage with one another, characterized in that theslots each have an entrance at one end and a transverse end block at theother end and the side rails each have a length less than that of thedistance from the entrance to the end block of their respective slot,allowing for lock out of incompatible mounting bases and connectorswhere at least one side rail is longer than the distance from theentrance to the end block of its corresponding slot. The system of FIG.26 may incorporate the coupling arrangements previously described toprovide further stability, as discussed above.

In the embodiment shown in FIG. 22, the connector also includes catches217 and 218, which can catch anti-rotation arms if they are formed withhooks, like the latch tips 98 of the test plug/connector. Theseanti-rotation components help to prevent rotation of the mountingbase/test plug and connector with respect to each other and also help toensure that the mounting base is only used with compatible testplugs/mounting bases, avoiding compatibility issues of physical ortechnical nature. In further embodiments, the width and/or height of theanti-rotation arms may be varied to lock-out previous noncompatiblecomponents. As shown in FIG. 34, it may be preferable for theanti-rotation arms 115, 116 of the mounting base 30 or test plug (notshown) to be at least as wide as they are tall to increase stability andfurther ward against rotation. If the anti-rotation arms are at least aswide as they are tall, they cannot be easily crushed or defeated and areless likely to fold over when pressure is applied. FIG. 35 shows apartial view of a connector 20 with widened rotation-arm recesses 215and 216, which also act as latch recesses for the latches on themounting base/test plug. The arrows 1000 are not part of the connector20 and are merely demonstrating that the rotation arm recesses 215 and216 have been widened to allow for the wider anti-rotation arms shown inFIG. 34.

With respect to the anti-rotation arm recesses, it is possible to havethe anti-rotation arm recesses be separate and distinct from the latchrecesses 100. However, in the figures shown herein, both the latches andthe anti-rotation arms fit into the rotation arm recesses 215, 216, suchthat the latch tips of the mounting base/test plug engage with thecatches 217 and 218 (shown in FIG. 22), and so that the latch recesses100 and latch keepers 102 for engaging the latch tips 98 are the samefeature as the rotation arm recesses 215, 216 and catches 217, 218.

In further embodiments, additional elements are included to providestability and lockout from incompatible components. For example, FIGS.30 and 31 show a mounting base 30 with lockout pillars 117 and 118.These lockout pillars 117 and 118 interact with and slide into lockoutpockets 217 and 218 in the connector 20, as shown in FIGS. 32 and 33(both showing partial views of the connector 20). The test plug (notshown) may be similarly modified to include lockout pillars that canslide into the lockout pockets 217 and 218. When the mounting base/testplug is connected to the connector, the lockout pillars further preventrotation between the components. In addition, they prevent the mountingbase/test plug being used with incompatible connectors that do not havethe matching lockout pockets (and, vice versa, they prevent use ofconnectors with incompatible mounting bases/test plugs). Although 2lockout pillars are shown in FIG. 30, it is possible to have anyreasonable number of lockout pillars that correspond with an equalnumber of lockout pockets on the connector.

The lockout pockets may be shaped by boring out a portion of theconnector, through injection molding of all or part of the connector, orthrough other methods of molding or formation of plastic parts known inthe art. The lockout pillars and lockout pockets are preferablyconstructed such that the lockout pillars fully fit into the lockoutpockets when the test plug or mounting base is connected to theconnector, when latch tips 98 fully engaged in the latch recesses 100,thus ensuring a tight connection of the test plug/mounting base with theconnector. This tight connection improves water resistance, stability ofparts and proper connection of electronic components. In furtherembodiments, material may be added into the pockets to create a moreunique shape. This more unique shape may be used to increase stabilityor to create a better lockout system using more specific interlockingcomponents with more particular shapes. Material can be added or removedto facilitate cleaning by changing the shape of pocket. Other benefitsof changing the shape of the pocket is to help inform the user whichlockout configuration they have or to allow sets of lockoutconfigurations. One of these configurations is shown in FIG. 33, wherethe added material 2170, 2180 is shown in the lockout pockets. The addedmaterial may be made from the same material as the rest of the connectoror a different material suitable for adding to the lockout pockets 217,218. Polycarbonate and polycarbonate blends (PC/ABS, PC/PBT, e.g.) arewell suited for added material because of their mechanical toughness andability to survive common sterilization methods, such as e-beam and ETO.However, any thermoplastic that is no-compressible would be sufficientas a material.

Additional embodiments are contemplated to provide stability and/orlockout from incompatible components. For example, in FIG. 26, a mock-upof the connecting portions of a mounting base and connector are shown,where the mounting base includes side rails 260 that fit into slots 262in the connector. FIGS. 27A-27F show various examples of combinations ofside rail lengths that could be used to lock out different versions ofthe mounting base and connector. As can be seen, the lengths of therails are set up to match the lengths of the slots so that a mountingbase with the incorrect rail lengths will not fit into a connector. Inthis configuration, the sensor set forms a base plate on which theconnectors rest, thus giving the connector and base plate the samefootprint, producing a more compact design. The connector slides ontothe sensor unit, which is upstanding on the base plate with the couplingwithin the body of the connector, thus providing more stability in theconnected condition, and it is less likely for the items to becomeaccidentally separated in use. The entire structure has a smooth profilehelping to reduce accidents, and the sliding engagement has rails ofvarying and different lengths (as per FIGS. 27A-27F), meaning that aconnector must be suited to the particular sensor unit for it to engageproperly.

In additional embodiments, the position of the anti-rotation armextensions may be varied with respect to the main body/central sectionof the test plug/mounting base. As an example, FIG. 19 shows a top viewof a test plug 130 with a main body/central section 35. The tubularelement 42 extends from the main body of the test plug. Extending fromthis main structure/central section are the anti-rotation arms 115 and116. The latch arms 97 are attached to yet separate from the centralsection of the mounting base or test plug, so that they may becompressed toward the central section 35 when latching into the latchrecesses 100 on the connector 20. When the mounting base or test plugconnects to the connector, the latch arms 97 move toward the centralsection until the latch tips 98 are fully within the latch recesses 100(or recesses 217, 218), snapping into place and locking the mountingbase/test plug from disconnecting away from the connector until a userwishes to disconnect the components.

In FIG. 36, however, the central section of the test plug or mountingbase (not shown) includes anti-rotation arm extensions 315, 316 betweenthe central section 35 and the anti-rotation arms 115, 116. Theanti-rotation arm extensions 315, 316 may slope from the top of thecentral section 35 down toward the anti-rotation arms. By includinganti-rotation arm extensions, especially those that slope down to theanti-rotation arms, it is possible to save materials when forming thetest plug or mounting base. The extensions further allow the pockets tobe cleaned while the test plug is connected. The extensions allow for amore consistent cross sectional thickness, which allows for faster timesduring molding and fewer cosmetic errors due to the effects of materialshrinkage.

Any of the particular features discussed herein that may be used tolock-out non-compatible components may be used alone or in combinationwith each other, creating many possible iterations of connectionconfigurations. Thus, it will be possible to ensure that many variationsof components that are not compatible will not be able to connect toeach other.

The sensor set of the present invention is mounted on the patient's skinquickly and easily to transcutaneously place the sensor 12. In onemethod, using the sensor in FIG. 4, for example, the mounting base 20and connector 20 are initially coupled together by engaging the snap fitlatch members. The hub 80 is also initially attached. The set is thenpressed against the patient's skin, typically after removing aprotective needle guard (not shown) and a release film (also not shown)from the underside of the adhesive patch 34 to expose a pressuresensitive adhesive thereon. Pressing the set against the skin causes theinsertion needle 14 to pierce the skin and thereby carry the cannula 58with the sensor electrodes 15 thereon to the desired subcutaneousposition. The insertion needle 14 is then slidably disengaged from thecannula and sensor by withdrawing the needle from the patient. Theinsertion set 10 can be affixed more securely to the patient, ifdesired, by an overdressing (not shown). Alternatively, the mountingbase may be affixed to the patient's skin before connecting to theconnector. Thus, the connector would be connected to the mounting baseafter the mounting base is comfortably attached to the skin of thepatient. It is also possible to disconnect the connector when thepatient wishes to shower or wash the components. At this point, a dummysocket (not shown) can be connected to the mounting base to protect theelectronic components inside the sensor.

When it is necessary or desirable to remove the sensor from the patient,the insertion set is simply removed from the patient's skin to withdrawthe sensor from the subcutaneous site. The insertion set 10 is quicklyand easily disassembled from the cable connector 20 by appropriaterelease of the snap fit latch members. A new insertion set 10 can thenassembled with the cable connector and quickly placed on the patient tosubcutaneously position a new sensor.

The foregoing description of specific embodiments reveals the generalnature of the disclosure sufficiently that others can, by applyingcurrent knowledge, readily modify and/or adapt the system and method forvarious applications without departing from the general concept.Therefore, such adaptations and modifications are within the meaning andrange of equivalents of the disclosed embodiments. The phraseology orterminology employed herein is for the purpose of description and not oflimitation.

What is claimed is:
 1. A mounting base for a sensor, the mounting basecomprising: a mounting base housing; a connector fitting generally at arear end of the mounting base housing, wherein the connector fittingincludes a cylindrical element having a central bore formed therein forpass through reception of a portion of a sensor, wherein the sensor hasat least two sensor electrodes thereon at a distal end for generating atleast one electrical signal representative of a characteristic of apatient, the sensor including at least two contact pads at a proximalend, wherein each of the at least two contact pads are conductivelycoupled to at least one of the at least two sensor electrodes; and ashim installed in the mounting base, wherein the shim is adapted toprevent pull up of the sensor.
 2. The mounting base of claim 1, furthercomprising one or more latch arms adapted to fit and lock into one ormore latch recesses on a connector, wherein the connector is adapted tocouple to the mounting base and to connect the sensor to sensorelectronics and includes a cylindrical recess sized to receive theconnector fitting of the mounting base and at least two connectorcontacts that are adapted to be electrically coupled to the at least twocontact pads of the sensor when the mounting base is coupled to theconnector.
 3. The mounting base of claim 2, further comprising one ormore lockout columns extending in the same direction as the one or morelatch recesses and the connector includes one or more lockout pocketsadapted to fit the lockout columns, wherein when the mounting base iscoupled to the connector.
 4. The mounting base of claim 2, furthercomprising one or more anti-rotation arms adapted to fit into one ormore anti-rotation recesses on the connector when the mounting base iscoupled to the connector.
 5. The mounting base of claim 4, wherein theone or more latch recesses are the same as the one or more anti-rotationarm recesses, such that the one or more latches fit into the samerecesses as the one or more anti-rotation arms.
 6. The mounting base ofclaim 1, wherein the shim is substantially triangular in shape.
 7. Themounting base of claim 1, wherein the shim minimizes friction betweenthe sensor and a needle used to insert the sensor into the patient. 8.The mounting base of claim 1, wherein the shim is installed in a cavitywithin the mounting base and the shim eliminates room for motion withinthe cavity of the mounting base.
 9. The mounting base of claim 1,wherein the sensor mounting base includes a recessed channel inside themounting base, wherein the recessed channel is adapted to hold thesensor and the shim.
 10. The mounting base of claim 1, wherein the shimimproves rigidity of the sensor.
 11. The mounting base of claim 1,wherein the mounting base is adapted to couple to the connector, whereinthe connector includes a cylindrical recess sized to receive theconnector fitting of the mounting base and at least two connectorcontacts that are adapted to be electrically coupled to the at least twocontact pads of the sensor when the mounting base is coupled to theconnector.
 12. The mounting base of claim 10, wherein the mounting baseincludes one or more latch arms and the connector includes one or morelatch recesses, and wherein the one or more latch arms are adapted tointo the one or more latch recesses when the mounting base is coupled tothe connector, and wherein the mounting base further includes one ormore anti-rotation arms and the connector includes one moreanti-rotation arm recesses, wherein the one or more anti-rotation armsare adapted to fit into the one or more anti-rotation arm recesses whenthe mounting base is coupled to the connector.
 13. The mounting base ofclaim 1, wherein the connector fitting includes a key formed at one end,wherein the proximal end of the sensor folds around the key such that atleast one of the at least two contact pads is on a first side of the keyand at least one other of the at least two contact pads is on a secondside of the key.
 14. A sensor set for sensing a characteristic of apatient, the sensor set comprising: a sensor having at least two sensorelectrodes thereon at a distal end for generating at least oneelectrical signal representative of a characteristic of a patient, thesensor including at least two contact pads at a proximal end, whereineach of the at least two contact pads are conductively coupled to atleast one of the at least two sensor electrodes; a mounting base adaptedto mount onto a patient's skin, the mounting base including mountingbase housing and a connector fitting generally at a rear end of themounting base housing, wherein the connector fitting includes acylindrical element having a central bore formed therein for passthrough reception of a portion of the sensor, a connector adapted tocouple to the mounting base and to connect the sensor to sensorelectronics, wherein the connector includes a cylindrical recess sizedto receive the connector fitting of the mounting base and at least twoconnector contacts that are adapted to be electrically coupled to the atleast two contact pads of the sensor when the mounting base is coupledto the connector, wherein the mounting base includes a shim installed inthe mounting base, wherein the shim is adapted to prevent pull up of thesensor when the sensor is inserted into the patient.
 15. The sensor setof claim 14, wherein the shim is substantially triangular in shape. 16.The sensor set of claim 14, wherein the shim minimizes friction betweenthe sensor and a needle used to insert the sensor into the patient. 17.The sensor set of claim 1, wherein the shim is installed in a cavitywithin the mounting base and the shim eliminates room for motion withinthe cavity of the mounting base.
 18. The sensor set of claim 1, whereinthe shim improves rigidity of the sensor.
 19. The sensor set of claim 1,wherein the sensor mounting base includes a recessed channel inside themounting base, wherein the recessed channel is adapted to hold thesensor and the shim.
 20. The sensor set of claim 14, wherein themounting base includes one or more latch arms and the connector includesone or more latch recesses, and wherein the one or more latch arms areadapted to into the one or more latch recesses when the mounting base iscoupled to the connector, and wherein the mounting base further includesone or more anti-rotation arms and the connector includes one moreanti-rotation arm recesses, wherein the one or more anti-rotation armsare adapted to fit into the one or more anti-rotation arm recesses whenthe mounting base is coupled to the connector.